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Trial record 5 of 42 for:    Recruiting, Not yet recruiting, Enrolling by invitation Studies | Astellas [Lead]

A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT03403790
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.

Condition or disease Intervention/treatment
Depression Bipolar Disorder Drug: Quetiapine

Detailed Description:
This is a post-marketing use-result survey study required for products in Japan. The investigator will register the patient who have been taking this product for the first time within 14 days after the start of treatment (inclusive of the start day). For each of the registered patients (including withdrawals and dropouts), the investigator will enter the survey data on the case report form.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use-results Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Group/Cohort Intervention/treatment
Patients with depression in bipolar disorder
Patients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time
Drug: Quetiapine
Oral (extended-release tablet)
Other Name: Bipresso




Primary Outcome Measures :
  1. Safety assessed by incidence of serious adverse events [ Time Frame: Up to Week 12 ]
    To assess incidence of serious adverse events as a criteria of safety variables.

  2. Safety assessed by incidence of adverse drug reactions [ Time Frame: Up to Week 12 ]
    To assess incidence of adverse drug reactions as a criteria of safety variables.

  3. Safety assessed by laboratory values and changes from baseline over time [ Time Frame: Up to Week 12 ]
    To assess profile of laboratory value transition and potential clinical significance as a criteria of safety variables. The investigators will assess the severity and clinical relevance, and will report as an adverse event as necessary.

  4. Safety assessed by vital signs: Blood pressure (sitting) [ Time Frame: Up to Week 12 ]
    To assess blood pressure as a criteria of safety variables

  5. Safety assessed by vital signs: Pulse rate (sitting) [ Time Frame: Up to Week 12 ]
    To assess pulse rate as a criteria of safety variables

  6. Safety assessed by 12-lead electrocardiogram [ Time Frame: Up to Week 12 ]
    To assess 12-lead electrocardiogram as a criteria of safety variables

  7. Safety assessed by body weight [ Time Frame: Up to Week 12 ]
    To assess body weight as a criteria of safety variables

  8. Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline and up to Week 12 ]
    To assess MADRS as a criteria of efficacy variables

  9. Change from baseline in Clinical Global Impression-Bipolar-Severity of illness (CGI-BP-S) [ Time Frame: Baseline and up to Week 12 ]
    To assess CGI-BP-S as a criteria of efficacy variables

  10. Efficacy assessed by Clinical Global Impression-Bipolar-Change (CGI-BP-C) [ Time Frame: Up to Week 12 ]
    To assess CGI-BP-C as a criteria of efficacy variables



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with depressive symptoms of bipolar disorder who have not been treated with quetiapine fumarate
Criteria

Inclusion Criteria:

  • Patients with depressive symptoms of bipolar disorder
  • Patients who have previously not been treated with quetiapine fumarate (immediate-release formulations of quetiapine fumarate and Bipresso Extended-Release Tablets)

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403790


Contacts
Contact: Astellas Pharma Inc. +81-3-3244-0512 astellas.registration@astellas.com

Locations
Japan
Site JP00023 Recruiting
Aichi, Japan
Site JP00005 Recruiting
Akita, Japan
Site JP00002 Recruiting
Aomori, Japan
Site JP00012 Recruiting
Chiba, Japan
Site JP00038 Recruiting
Ehime, Japan
Site JP00018 Recruiting
Fukui, Japan
Site JP00040 Recruiting
Fukuoka, Japan
Site JP00007 Recruiting
Fukushima, Japan
Site JP00021 Recruiting
Gifu, Japan
Site JP00010 Recruiting
Gunma, Japan
Site JP00034 Recruiting
Hiroshima, Japan
Site JP00001 Recruiting
Hokkaido, Japan
Site JP00028 Recruiting
Hyogo, Japan
Site JP00008 Recruiting
Ibaraki, Japan
Site JP00017 Recruiting
Ishikawa, Japan
Site JP00003 Recruiting
Iwate, Japan
Site JP00037 Recruiting
Kagawa, Japan
Site JP00046 Recruiting
Kagoshima, Japan
Site JP00014 Recruiting
Kanagawa, Japan
Site JP00039 Recruiting
Kochi, Japan
Site JP00043 Recruiting
Kumamoto, Japan
Site JP00026 Recruiting
Kyoto, Japan
Site JP00024 Recruiting
Mie, Japan
Site JP00004 Recruiting
Miyagi, Japan
Site JP00045 Recruiting
Miyazaki, Japan
Site JP00020 Recruiting
Nagano, Japan
Site JP00042 Recruiting
Nagasaki, Japan
Site JP00029 Recruiting
Nara, Japan
Site JP00015 Recruiting
Niigata, Japan
Site JP00044 Recruiting
Oita, Japan
Site JP00033 Recruiting
Okayama, Japan
Site JP00047 Recruiting
Okinawa, Japan
Site JP00027 Recruiting
Osaka, Japan
Site JP00041 Recruiting
Saga, Japan
Site JP00011 Recruiting
Saitama, Japan
Site JP00025 Recruiting
Shiga, Japan
Site JP00032 Recruiting
Shimane, Japan
Site JP00022 Recruiting
Shizuoka, Japan
Site JP00009 Recruiting
Tochigi, Japan
Site JP00036 Recruiting
Tokushima, Japan
Site JP00013 Recruiting
Tokyo, Japan
Site JP00031 Recruiting
Tottori, Japan
Site JP00016 Recruiting
Toyama, Japan
Site JP00030 Recruiting
Wakayama, Japan
Site JP00006 Recruiting
Yamagata, Japan
Site JP00035 Recruiting
Yamaguchi, Japan
Site JP00019 Recruiting
Yamanashi, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT03403790     History of Changes
Other Study ID Numbers: 6949-MA-3199
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc:
Bipresso
Drug use-results survey
Quetiapine

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs